NCT05669430

A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

An Open-Label Phase 1/2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and/or Refractory Solid Tumor Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 365 (estimated)
• Sponsor: GV20 Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2A study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.

Detailed description

This is a Phase 1/2A non-randomized, open label, multi-center study to be conducted in four parts (Parts A, B, C and D). In Part A, a 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D). In Part B, the Bayesian optimal design for Phase II (BOP2) will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D across multiple expansion cohorts involving eligible participants. In Part C, the Bayesian optimal interval (BOIN) design will be employed to evaluate the safety and tolerability of GV20-0251 in combination with Pembrolizumab, and to determine the MTD or the preliminary RP2D of this combination. In Part D, BOP2 will be applied to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 in combination with Pembrolizumab at the preliminary RP2D across multiple expansion cohorts involving eligible participants.

Conditions

• Solid Tumor, Adult
• Refractory Cancer
• Endometrial Carcinoma (EC)
• Squamous Head and Neck Carcinoma
• pMMR/MSS Adenocarcinoma of the Colon or Rectum
• Cutaneous Melanoma
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	GV20-0251	Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.
BIOLOGICAL	GV20-0251	GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.
BIOLOGICAL	GV20-0251 and Pembrolizumab [KEYTRUDA®]	GV20-0251 administered by IV infusion at 10 mg/kg once every 3 weeks or at increasing doses up to the preliminary RP2D determined in Part A. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.
BIOLOGICAL	GV20-0251 and Pembrolizumab [KEYTRUDA®]	GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.

Timeline

• Start date: 2023-03-23
• Primary completion: 2026-12-15
• Completion: 2027-09-05
• First posted: 2022-12-30
• Last updated: 2025-02-13

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study